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Details for New Drug Application (NDA): 020883
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The generic ingredient in ARGATROBAN is argatroban. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the argatroban profile page.
Summary for 020883
Tradename: | ARGATROBAN |
Applicant: | Novartis |
Ingredient: | argatroban |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020883
Mechanism of Action | Thrombin Inhibitors |
Suppliers and Packaging for NDA: 020883
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883 | NDA | Novartis Pharmaceuticals Corporation | 0078-0930 | 0078-0930-61 | 1 VIAL in 1 CARTON (0078-0930-61) > 2.5 mL in 1 VIAL |
Paragraph IV (Patent) Challenges for 020883
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
ARGATROBAN | INJECTABLE;INJECTION | argatroban | 020883 | 2007-09-24 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 250MG/2.5ML (100MG/ML) | ||||
Approval Date: | Jun 30, 2000 | TE: | AP | RLD: | Yes |
Expired US Patents for NDA 020883
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883-001 | Jun 30, 2000 | Start Trial | Start Trial |
Novartis | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883-001 | Jun 30, 2000 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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